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U.S. Department of Health and Human Services

CLIA - Clinical Laboratory Improvement Amendments
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Document Number CR240193
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Document Parent Analyte Analyte Specialty Complexity Effective Date
Genabio Diagnostics Inc., GenaCheck™ Fentanyl Urine Test Cassette  
CR240193 K233417 Fentanyl Toxicology / TDM WAIVED 05/08/2024
Genabio Diagnostics Inc., GenaCheck™ Fentanyl Urine Home-Use Test Cassette  
CR240193 K233417 Fentanyl Toxicology / TDM WAIVED 05/08/2024

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